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DESCRIPTIONHip resurfacing is an alternative to total hip arthroplasty (THA, also known as hip replacement) for patients with advanced arthritis of the hip. Total hip resurfacing (THR) describes the placement of a shell that covers the femoral head together with implantation of an acetabular cup in patients with painful hip joints. Partial hip resurfacing is considered a treatment option for avascular necrosis with collapse of the femoral head. Hip resurfacing may be considered an alternative to total hip arthroplasty, particularly in young active patients who would potentially outlive a total hip prosthesis. Total hip resurfacing, investigated in a broader range of patients including those with osteoarthritis, rheumatoid arthritis, and advanced avascular necrosis, may be considered an alternative to total hip arthroplasty, particularly in young active patients who would potentially outlive a total hip prosthesis. Therefore, hip resurfacing could be viewed as a time-buying procedure to delay the need for a total hip arthroplasty. Proposed advantages of total hip resurfacing compared to total hip arthroplasty include preservation of the femoral neck and femoral canal, thus facilitating revision or conversion to a total hip resurfacing, if required. In addition, the resurfaced head is more similar in size to the normal femoral head, thus increasing the stability and decreasing the risk of dislocation compared to total hip arthroplasty.
Total hip resurfacing has undergone various evolutions over the past several decades, with modifications in prosthetic design and composition and implantation techniques. For example, similar to total hip prostheses, the acetabular components of total hip resurfacing have been composed of polyethylene. However, over the years it has become apparent that device failure was frequently related to the inflammatory osteolytic reaction to polyethylene debris wear particles. Metal acetabular components have since been designed to improve implant longevity. Sensitivity to wear particles from metal-on-metal (MoM) chromium and cobalt implant components are of increasing concern.
In January 2013, FDA issued a safety communication on metal-on-metal hip implants (both total hip resurfacing and total hip replacement). FDA has provided updated safety information and recommendations to patients and health care providers. This new information is based on FDA’s current assessment of metal-on-metal hip implants, including the benefits and risks, the evaluation of the published literature, and the results of the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel meeting. As of January 2013, FDA stated that it had insufficient scientific data to specify a concentration of metal ions in a patient’s body or blood that would produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.
In May 2006, the Birmingham Hip Resurfacing system was approved by FDA through the premarket approval (PMA) process for use in patients requiring primary hip resurfacing arthroplasty for non-inflammatory or inflammatory arthritis. This decision was primarily based on a series of 2,385 patients who received this device by a single surgeon in England. A number of post-approval requirements were agreed to, including the following items:
The Cormet™ Hip Resurfacing System (Corin) and the Conserve® Plus (Wright Medical Technology) are metal-on-metal total hip resurfacing systems that were FDA approved in 2007 and 2009, respectively. The approval order for the Cormet system states that the device is intended for use in resurfacing hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions: 1) non-inflammatory degenerative arthritis such as osteoarthritis and avascular necrosis; 2) inflammatory arthritis such as rheumatoid arthritis. The Cormet Hip Resurfacing System is intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.
Various devices have been cleared for marketing by FDA through the 510(k) process for partial hip (femoral) resurfacing. Some surgeons may be using a femoral resurfacing component together with an acetabular cup (total arthroplasty component) as an "off-label" application.
In January 2013, FDA issued a safety communication on metal-on-metal hip implants (including both hip resurfacing and hip replacement). FDA stated that metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants.
Presently, FDA does not have enough scientific data to specify the concentration of metal ions in a patient’s body or blood necessary to produce adverse systemic effects. In addition, the reaction seems to be specific to individual patients, with different patients having different reactions to the metal wear particles.Also, see the Surgical Treatment of Femoroacetabular Impingement medical policy.
POLICYMetal-on-metal total hip resurfacing with an FDA approved device system may be considered medically necessary as an alternative to total hip replacement when the patient:
Partial hip resurfacing with an FDA-approved device may be considered medically necessary in patients with osteonecrosis of the femoral head who have one or more contraindications for metal-on-metal implants and meet the following criteria:
All other types and applications of total hip resurfacing are considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
POLICY GUIDELINESThe U.S. Food and Drug Administration (FDA) lists several contraindications for total hip resurfacing. These contraindications include (not a complete listing) the following:
-Bone stock inadequate to support the device due to:
-Vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery
-Known moderate to severe renal insufficiency
-Known or suspected metal sensitivity
-Immunosuppressed or receiving high doses of corticosteroids
-Females of child bearing age due to unknown effects on the fetus of metal ion release
A 2012 FDA advisory panel of experts identified young males with larger femoral heads as the best candidates for hip resurfacing systems. The FDA advises that a metal-on-metal hip implant should be selected only after determining that the benefit-risk profile of using a metal-on-metal hip implant outweighs that of using an alternative hip system. Factors to consider include the patient’s age, sex, weight, diagnosis, and activity level. Patients should be informed about the benefits and risks of metal-on-metal hip implants, including the risk that the hip implant may need to be replaced. Patient expectations and the potential complications of surgery with a metal-on-metal hip implant should be discussed.
Total hip resurfacing should be performed by surgeons who are adequately trained and experienced in the specific techniques and devices used.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/2001: Approved Medical Policy Advisory Committee (MPAC)
2/7/2002: Investigational definition added
5/8/2002: Type of Service and Place of Service deleted
11/3/2004: Code Reference section completed
2/18/2005: Policy reviewed, no changes
3/13/2006: Policy reviewed, devices were updated, investigational policy statement unchanged
9/18/2006: Coding updated. ICD9 2006 revisions added to policy
4/30/2007: Policy updated to allow for metal-on-metal total hip resurfacing. CPT 27299, ICD-9 procedures 00.85 and 81.40 moved to covered. Added ICD-9 diagnosis 714.0, 715.0-715.9, 733.42
5/16/2007: Policy reviewed, description updated. Added "who do not have contraindications for total hip resurfacing," and removed "who are likely to out live a traditional prosthesis," under the Policy section
7/19/2007: Reviewed and approved by MPAC
6/24/2008: Policy reviewed, no changes
8/26/2008: Quarterly HCPCS code updates applied
08/18/2010: Policy description updated regarding FDA approval of devices and treatment approaches. The total resurfacing policy statement was revised to add “is likely to outlive a traditional prosthesis” to the criteria. Added policy statements for partial resurfacing, which is considered medically necessary in specific conditions. Supporting explanations added to the policy guidelines. FEP verbiage added to the Policy Exceptions section. Added ICD-9 procedure codes 00.75, 00.86, and 00.87.
07/29/2011: Deleted "Total" from the policy title to align with the scope of the policy statement. Policy statement unchanged.
07/12/2012: Policy reviewed; no changes.
10/17/2013: Policy reviewed; no changes to policy statement. Policy guidelines updated regarding patient selection criteria.
11/25/2014: Policy reviewed; description updated regarding devices and metal-on-metal implants. Policy statements unchanged.
08/25/2015: Code Reference section updated for ICD-10.
11/06/2015: Policy description updated regarding metal-on-metal hip implants. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.
05/31/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 7.01.80
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.